Day 1 : Tuesday, October 18
9:00 am - 3:00 pm
Pre-Conference Workshop - Clinical Supplies Foundations (Boot Camp)
The attendee will be able to
• Describe at least three (3) historical events that drove the development of GMPs.
• Identify no fewer than three (3) quality rules to ensure IMP production meets global regulatory standards.
• List three (3) regulatory requirements when shipping temperature-controlled IMPs.
Speakers:
Day 2 : Wednesday, October 19
10:15 am - 11:15 am
Cultural Challenges
The attendee will be able to:
1.) Explain no fewer than two (2) new trends in Clinical Trials outsourcing and how they could impact clinical supplies planning and forecasting and delivery.
2.) Describe the root cause of any changes in outsourcing that are effecting clinical supplies
3.) Summarize how the current trends in clinical trial outsourcing will continue over the next few years
1.) Explain no fewer than two (2) new trends in Clinical Trials outsourcing and how they could impact clinical supplies planning and forecasting and delivery.
2.) Describe the root cause of any changes in outsourcing that are effecting clinical supplies
3.) Summarize how the current trends in clinical trial outsourcing will continue over the next few years
Speakers:
10:15 am - 11:15 am
eLabels: Advantages and controls related to eLabel process.
The attendee will be able to:
(1) Summarize how e-labels work and how they can eliminate expiry date update requirements
(2) Compare and contrast how e-labels will be used on IMPs versus standard booklet labels
(3) List 2 out of 3 technical requirements required if you transition to e-labeling
(1) Summarize how e-labels work and how they can eliminate expiry date update requirements
(2) Compare and contrast how e-labels will be used on IMPs versus standard booklet labels
(3) List 2 out of 3 technical requirements required if you transition to e-labeling
Speakers:
10:15 am - 11:15 am
Emotional Intelligence: Difficult conversations
The attendee will be able to:
1.) Identify no less than four (4) key tenants of Emotional Intelligence
2.) Compare and contrast the value of a high Emotional Quotient (EQ) versus a high Intelligence Quotient (IQ)
3.) Define the key skill and the key tool necessary to successfully have difficult conversations
1.) Identify no less than four (4) key tenants of Emotional Intelligence
2.) Compare and contrast the value of a high Emotional Quotient (EQ) versus a high Intelligence Quotient (IQ)
3.) Define the key skill and the key tool necessary to successfully have difficult conversations
Speakers:
10:15 am - 11:15 am
Fast Track Phase 1 studies: Shortening timelines to 1 month
The attendee will be able to:
1.) Determine no less than two (2) ways to shorten Phase 1 studies through increased efficiencies in clinical supplies management
2.) Explain the reason why shortening phase I trials has become such a high priority in drug development
3.) Differentiate between standard Phase I clinical trial requirements and Fast Track Phase I clinical trial requirements
1.) Determine no less than two (2) ways to shorten Phase 1 studies through increased efficiencies in clinical supplies management
2.) Explain the reason why shortening phase I trials has become such a high priority in drug development
3.) Differentiate between standard Phase I clinical trial requirements and Fast Track Phase I clinical trial requirements
Speakers:
10:15 am - 11:15 am
Who should be importer of record?
The attendee will be able to:
1.) Give one example of a distribution challenge where Importer of Record was a necessary part of the documentation
2.) Compare and contrast successful and unsuccessful methodologies for documenting importation
3.) Identify at least one (1) person that can sign on the importer of record document
1.) Give one example of a distribution challenge where Importer of Record was a necessary part of the documentation
2.) Compare and contrast successful and unsuccessful methodologies for documenting importation
3.) Identify at least one (1) person that can sign on the importer of record document
Speakers:
11:30 am - 12:30 pm
Approval process for temperature controlled shipments
The attendee will be able to:
1.) Explain the importance of having an approval process for temperature controlled IMP shipments
2.) Give examples of what can go wrong during temperature controlled distribution of IMPs
3.) Summarize how the Good Distribution Practices (GDPs) have had an impact on temprature controlled shipments of IMPs
1.) Explain the importance of having an approval process for temperature controlled IMP shipments
2.) Give examples of what can go wrong during temperature controlled distribution of IMPs
3.) Summarize how the Good Distribution Practices (GDPs) have had an impact on temprature controlled shipments of IMPs
Speakers:
11:30 am - 12:30 pm
Influencing without authority
The attendee will be able to:
1.) Identify the challenges of getting people to execute tasks without a direct line of authority
2.) List no less than two (2) ways leaders can motivate team members to accomplish goals in a mtrixed organization
3.) Give examples of how an IMP manager can influence stakeholders in order to get the best outcomes for everyone
1.) Identify the challenges of getting people to execute tasks without a direct line of authority
2.) List no less than two (2) ways leaders can motivate team members to accomplish goals in a mtrixed organization
3.) Give examples of how an IMP manager can influence stakeholders in order to get the best outcomes for everyone
Speakers:
11:30 am - 12:30 pm
Innovation in ensuring patient compliance
The attendee will be able to:
1.) List no less than two (2) reasons why patients are not always compliant in taking their IMPs
2.) Summarize how dosing schedule, size, taste, and amount of dosages to be taken at a given time will impact patient compliance
3.) Present no less than two (2) new concepts that will increase patient compliance with IMPs
1.) List no less than two (2) reasons why patients are not always compliant in taking their IMPs
2.) Summarize how dosing schedule, size, taste, and amount of dosages to be taken at a given time will impact patient compliance
3.) Present no less than two (2) new concepts that will increase patient compliance with IMPs
Speakers:
11:30 am - 12:30 pm
Investigator Initiated Trials: Challenges in Supporting
The attendee will be able to:
(1) Identify at least two (2) regulatory hurdles that must be overcome when conducting global IITs
(2) List two (2) things that a clinical supplies project manager must keep track of and control when conducting IITs
(3) Compare and contrast the clinical supplies requirements between standard clinical trials and IITs
(1) Identify at least two (2) regulatory hurdles that must be overcome when conducting global IITs
(2) List two (2) things that a clinical supplies project manager must keep track of and control when conducting IITs
(3) Compare and contrast the clinical supplies requirements between standard clinical trials and IITs
Speakers:
11:30 am - 12:30 pm
Who should be importer of record?
The attendee will be able to:
1.) Give one example of a distribution challenge where Importer of Record was a necessary part of the documentation
2.) Compare and contrast successful and unsuccessful methodologies for documenting importation
3.) Identify at least one (1) person that can sign on the importer of record document
1.) Give one example of a distribution challenge where Importer of Record was a necessary part of the documentation
2.) Compare and contrast successful and unsuccessful methodologies for documenting importation
3.) Identify at least one (1) person that can sign on the importer of record document
Speakers:
3:00 pm - 4:00 pm
Cost Transparency in Clinical Supplies World
The attendee will be able to:
1.) Identify no fewer than two (2) key aspects of financial tracking and control for IMPs
2.) Explain the benifits of understanding IMP planning and forecasting Return on Investment (ROI)
3.) Give examples of where high levels of waste exist in the IMP supply chain and how to reduce them
1.) Identify no fewer than two (2) key aspects of financial tracking and control for IMPs
2.) Explain the benifits of understanding IMP planning and forecasting Return on Investment (ROI)
3.) Give examples of where high levels of waste exist in the IMP supply chain and how to reduce them
Speakers:
3:00 pm - 4:00 pm
Cultural Challenges
The attendee will be able to:
1.) Explain no fewer than two (2) new trends in Clinical Trials outsourcing and how they could impact clinical supplies planning and forecasting and delivery.
2.) Describe the root cause of any changes in outsourcing that are effecting clinical supplies
3.) Summarize how the current trends in clinical trial outsourcing will continue over the next few years
1.) Explain no fewer than two (2) new trends in Clinical Trials outsourcing and how they could impact clinical supplies planning and forecasting and delivery.
2.) Describe the root cause of any changes in outsourcing that are effecting clinical supplies
3.) Summarize how the current trends in clinical trial outsourcing will continue over the next few years
Speakers:
3:00 pm - 4:00 pm
Emotional Intelligence: Difficult conversations
The attendee will be able to:
1.) Identify no less than four (4) key tenants of Emotional Intelligence
2.) Compare and contrast the value of a high Emotional Quotient (EQ) versus a high Intelligence Quotient (IQ)
3.) Define the key skill and the key tool necessary to successfully have difficult conversations
1.) Identify no less than four (4) key tenants of Emotional Intelligence
2.) Compare and contrast the value of a high Emotional Quotient (EQ) versus a high Intelligence Quotient (IQ)
3.) Define the key skill and the key tool necessary to successfully have difficult conversations
Speakers:
3:00 pm - 4:00 pm
Fast Track Phase 1 studies: Shortening timelines to 1 month
The attendee will be able to:
1.) Determine no less than two (2) ways to shorten Phase 1 studies through increased efficiencies in clinical supplies management
2.) Explain the reason why shortening phase I trials has become such a high priority in drug development
3.) Differentiate between standard Phase I clinical trial requirements and Fast Track Phase I clinical trial requirements
1.) Determine no less than two (2) ways to shorten Phase 1 studies through increased efficiencies in clinical supplies management
2.) Explain the reason why shortening phase I trials has become such a high priority in drug development
3.) Differentiate between standard Phase I clinical trial requirements and Fast Track Phase I clinical trial requirements
Speakers:
3:00 pm - 4:00 pm
Influencing without authority
The attendee will be able to:
1.) Identify the challenges of getting people to execute tasks without a direct line of authority
2.) List no less than two (2) ways leaders can motivate team members to accomplish goals in a mtrixed organization
3.) Give examples of how an IMP manager can influence stakeholders in order to get the best outcomes for everyone
1.) Identify the challenges of getting people to execute tasks without a direct line of authority
2.) List no less than two (2) ways leaders can motivate team members to accomplish goals in a mtrixed organization
3.) Give examples of how an IMP manager can influence stakeholders in order to get the best outcomes for everyone
Speakers:
Day 3 : Thursday, October 20
10:00 am - 11:00 am
Cost Transparency in Clinical Supplies World
The attendee will be able to:
1.) Identify no fewer than two (2) key aspects of financial tracking and control for IMPs
2.) Explain the benifits of understanding IMP planning and forecasting Return on Investment (ROI)
3.) Give examples of where high levels of waste exist in the IMP supply chain and how to reduce them
1.) Identify no fewer than two (2) key aspects of financial tracking and control for IMPs
2.) Explain the benifits of understanding IMP planning and forecasting Return on Investment (ROI)
3.) Give examples of where high levels of waste exist in the IMP supply chain and how to reduce them
Speakers:
10:00 am - 11:00 am
eLabels: Advantages and controls related to eLabel process.
The attendee will be able to:
(1) Summarize how e-labels work and how they can eliminate expiry date update requirements
(2) Compare and contrast how e-labels will be used on IMPs versus standard booklet labels
(3) List 2 out of 3 technical requirements required if you transition to e-labeling
(1) Summarize how e-labels work and how they can eliminate expiry date update requirements
(2) Compare and contrast how e-labels will be used on IMPs versus standard booklet labels
(3) List 2 out of 3 technical requirements required if you transition to e-labeling
Speakers:
10:00 am - 11:00 am
Emotional Intelligence: Difficult conversations
The attendee will be able to:
1.) Identify no less than four (4) key tenants of Emotional Intelligence
2.) Compare and contrast the value of a high Emotional Quotient (EQ) versus a high Intelligence Quotient (IQ)
3.) Define the key skill and the key tool necessary to successfully have difficult conversations
1.) Identify no less than four (4) key tenants of Emotional Intelligence
2.) Compare and contrast the value of a high Emotional Quotient (EQ) versus a high Intelligence Quotient (IQ)
3.) Define the key skill and the key tool necessary to successfully have difficult conversations
Speakers:
10:00 am - 11:00 am
Fast Track Phase 1 studies: Shortening timelines to 1 month
The attendee will be able to:
1.) Determine no less than two (2) ways to shorten Phase 1 studies through increased efficiencies in clinical supplies management
2.) Explain the reason why shortening phase I trials has become such a high priority in drug development
3.) Differentiate between standard Phase I clinical trial requirements and Fast Track Phase I clinical trial requirements
1.) Determine no less than two (2) ways to shorten Phase 1 studies through increased efficiencies in clinical supplies management
2.) Explain the reason why shortening phase I trials has become such a high priority in drug development
3.) Differentiate between standard Phase I clinical trial requirements and Fast Track Phase I clinical trial requirements
Speakers:
10:00 am - 11:00 am
Who should be importer of record?
The attendee will be able to:
1.) Give one example of a distribution challenge where Importer of Record was a necessary part of the documentation
2.) Compare and contrast successful and unsuccessful methodologies for documenting importation
3.) Identify at least one (1) person that can sign on the importer of record document
1.) Give one example of a distribution challenge where Importer of Record was a necessary part of the documentation
2.) Compare and contrast successful and unsuccessful methodologies for documenting importation
3.) Identify at least one (1) person that can sign on the importer of record document
Speakers:
11:15 am - 12:15 pm
Approval process for temperature controlled shipments
The attendee will be able to:
1.) Explain the importance of having an approval process for temperature controlled IMP shipments
2.) Give examples of what can go wrong during temperature controlled distribution of IMPs
3.) Summarize how the Good Distribution Practices (GDPs) have had an impact on temprature controlled shipments of IMPs
1.) Explain the importance of having an approval process for temperature controlled IMP shipments
2.) Give examples of what can go wrong during temperature controlled distribution of IMPs
3.) Summarize how the Good Distribution Practices (GDPs) have had an impact on temprature controlled shipments of IMPs
Speakers:
11:15 am - 12:15 pm
Cultural Challenges
The attendee will be able to:
1.) Explain no fewer than two (2) new trends in Clinical Trials outsourcing and how they could impact clinical supplies planning and forecasting and delivery.
2.) Describe the root cause of any changes in outsourcing that are effecting clinical supplies
3.) Summarize how the current trends in clinical trial outsourcing will continue over the next few years
1.) Explain no fewer than two (2) new trends in Clinical Trials outsourcing and how they could impact clinical supplies planning and forecasting and delivery.
2.) Describe the root cause of any changes in outsourcing that are effecting clinical supplies
3.) Summarize how the current trends in clinical trial outsourcing will continue over the next few years
Speakers:
11:15 am - 12:15 pm
Influencing without authority
The attendee will be able to:
1.) Identify the challenges of getting people to execute tasks without a direct line of authority
2.) List no less than two (2) ways leaders can motivate team members to accomplish goals in a mtrixed organization
3.) Give examples of how an IMP manager can influence stakeholders in order to get the best outcomes for everyone
1.) Identify the challenges of getting people to execute tasks without a direct line of authority
2.) List no less than two (2) ways leaders can motivate team members to accomplish goals in a mtrixed organization
3.) Give examples of how an IMP manager can influence stakeholders in order to get the best outcomes for everyone
Speakers:
11:15 am - 12:15 pm
Innovation in ensuring patient compliance
The attendee will be able to:
1.) List no less than two (2) reasons why patients are not always compliant in taking their IMPs
2.) Summarize how dosing schedule, size, taste, and amount of dosages to be taken at a given time will impact patient compliance
3.) Present no less than two (2) new concepts that will increase patient compliance with IMPs
1.) List no less than two (2) reasons why patients are not always compliant in taking their IMPs
2.) Summarize how dosing schedule, size, taste, and amount of dosages to be taken at a given time will impact patient compliance
3.) Present no less than two (2) new concepts that will increase patient compliance with IMPs
Speakers:
11:15 am - 12:15 pm
Investigator Initiated Trials: Challenges in Supporting
The attendee will be able to:
(1) Identify at least two (2) regulatory hurdles that must be overcome when conducting global IITs
(2) List two (2) things that a clinical supplies project manager must keep track of and control when conducting IITs
(3) Compare and contrast the clinical supplies requirements between standard clinical trials and IITs
(1) Identify at least two (2) regulatory hurdles that must be overcome when conducting global IITs
(2) List two (2) things that a clinical supplies project manager must keep track of and control when conducting IITs
(3) Compare and contrast the clinical supplies requirements between standard clinical trials and IITs
Speakers:
